Current trends in the pharmaceutical industry are toward the development of antibody and other protein-based pharmaceuticals. These drugs have the advantage of selectively targeting binding sites in the body. The drugs, sometimes classified as “biologics,” are often produced by cell cultures in fermentation reactors with volumes ranging from of 3 L to 10000 L. To prevent the growth of foreign cells or pathogens, the sterility of the reactor must be maintained at all times. Therefore, real time analysis of the reactor contents and characteristics is limited, as the time and labor required to gather samples and generate data, results in an information gap; typically meaningful data can take hours or days to develop.
Further, current devices capable of maintaining sterility and quantifying the drug, nutrient metabolytes and or other analytes as the fermentation progresses are limited in that they can only measure these when the concentrations are high. Current devices capable of maintaining sterility and quantifying the nutrient levels as the fermentation progresses are limited in that they can only measure the nutrient levels at the beginning of the batch when the concentration are high. This causes windows of time when the analyte levels are not measurable.